Hydrocortisone Acetate
Hydrocortisone Acetate is an FDA drug label for the active ingredient HYDROCORTISONE ACETATE manufactured by Cosette Pharmaceuticals, Inc. administered by RECTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231123.
- Generic name
- HYDROCORTISONE ACETATE
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- RECTAL
- Dosage form
- N/A
- NDC
- 0713-0493
- Application
- N/A
- Label effective
- 20231123
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone Acetate Suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual dosage: One suppository in the rectum twice daily morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
Contraindications
CONTRAINDICATIONS Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.
Warnings
Not available.
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories: 1. Burning 5. Folliculitis 2. Itching 6. Hypopigmentation 3. Irritation 7. Allergic Contact Dermatitis 4. Dryness 8. Secondary Infection To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .